Adiposity Distribution in Acute Respiratory Failure

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMaurizio F. Cereda, MD

About this trial

Acute Hypoxemic Respiratory Failure (AHRF) is a condition in which injury to the lungs impairs the ability of the air sacs (alveoli) to ventilate and exchange oxygen. This impairment may be worsened in individuals with elevated body weight, particularly when fat tissue compresses the lungs and promotes alveolar collapse. The impact of body weight on lung function may be greater in individuals with upper-body fat distribution.

Two common interventions for AHRF-positive end-expiratory pressure (PEEP) and prone positioning-are used to improve lung ventilation. However, it is unclear whether these therapies are equally effective across different body weight categories and fat distributions.

This study will evaluate whether body weight and fat distribution affect patients' lung inflation responses to PEEP and prone positioning. Lung inflation will be assessed using electrical impedance tomography (EIT), a bedside imaging tool that maps lung ventilation, and esophageal manometry, which estimates lung compression through a thin catheter placed in the esophagus. Laboratory tests will also be used to measure markers of inflammation and AHRF severity and find correlations with fat distribution and responses to the tested treatments..

Patients with AHRF requiring mechanical ventilation will be enrolled across a range of body weights. Each participant will undergo combinations of two PEEP levels and two body positions (supine and prone) for 30 minutes each. At the end of the study procedures, clinical care will continue as determined by the treating team.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

AHRF with PaO2/FiO2 <= 300 mmHg) intubated for less than 72 hours

Presence of an arterial line for blood gas measurement and blood pressure monitoring

18 years or older

Disqualifiers

Suspected pregnancy, pregnancy or less than six weeks postpartum

Younger than 18 years or older than 80 years.

Subject enrolled in another interventional research study

Presence of pneumothorax

Trial design

Design model

Single group

Treatments tested in this trial

  • PEEP Titration Using Electrical Impedance Tomography (EIT)

    Other intervention

    EIT will be used to guide individualized PEEP titration in mechanically ventilated patients with AHRF. Each subject will receive mechanical ventilation at two PEEP levels: PEEP\_CLIN (set by the treating clinician) PEEP\_TIT (identified using EIT to minimize alveolar collapse and overdistension) Both levels will be maintained for 30 minutes in each body position, with continuous physiologic data collected during each phase.

  • Body Positioning: Supine and Prone

    Procedure/Surgery

    Each subject will be ventilated in both the supine and prone positions. Positioning will follow institutional protocols and be coordinated with clinical staff to ensure safety. After supine assessments are completed, the patient will be transitioned to prone, followed by a recruitment maneuver to standardize lung volume history. The PEEP titration protocol will then be repeated in the prone position.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Single Arm: Ventilatory Assessment at Two PEEP Levels and Body PositionsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Driving pressure with PEEP titration and prone position

The primary outcome will be the difference in driving pressure (inspiratory plateau pressure minus total PEEP, in cmH2O) in response to PEEP titration strategies and to prone position. Changes in driving pressure will be correlated with body mass index, and with measurements of thoracic, and abdominal circumference.

Time frame
Day 1, after 30 minutes in each combination of PEEP and body position

Secondary outcomes

1

Regional ventilation

Changes in EIT-derived measurements of regional ventilation with PEEP titration and prone positioning. EIT regional ventilation is measured as percentage of total ventilation in each examined lung region.

Time frame
Day 1, after 30 minutes in each combination of PEEP and body position

Other outcomes

1

Age

Age will be measured in years.

Time frame
Day 1
2

Height

Body height will be measured in meters and will be aggregated with body weight to yield body mass index (BMI) in kg/m\^2.

Time frame
Day 1
3

Weight

Body weight will be measured in kg and will be aggregated with height to yield body mass index (BMI) in kg/m\^2

Time frame
Day 1
4

Thoracic circumference

Thoracic circumference will be measured in cm using a tape ruler placed at nipple level.

Time frame
Day 1

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maurizio F. Cereda, MD

Lead sponsor

Massachusetts General Hospital

Sponsor institution

National Institutes of Health (NIH)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: